SAEM Board of Directors Members Respond to Press About Emergency Medicine Research Using the FDA Rule for Exception to Informed Consent
On May 27, the Washington Post published an article by Rob Stein regarding the use of the FDA rule for the exception to informed consent by the Resuscitation Outcomes consortium, entitled Critical Care Without Consent: Ethicists Disagree on Experimenting During Crisis. The article cited both supporters and critics of the rule, including that by bioethicist George J. Annas (Boston University) who was quoted as saying "this seems like lazy investigators not wanting to try to get informed consent..." An editorial in the Toledo Blade on June 7, entitled Consent is Always Vital also criticized the rule for exception to informed consent. On behalf of the SAEM Board of Directors, Catherine Marco and Jill Baren responded to both articles with a letter to the editor (below) to the Washington Post which has not been published and to the Toledo Blade which appeared on June 19th.
(posted September 2007)
Editorial Response
Save a Life – Save Many Lives: Emergency Medicine Research
To The Editor:
We read with interest the article published in the Washington Post on May 27, 2007: “Critical Care Without Consent”. We applaud Rob Stein for bringing important issues about emergency research to national attention. As the largest organization of emergency medicine researchers in the world, SAEM plays a crucial role shaping the emergency medicine research agenda and in performing much needed research on a wide variety of emergency conditions which affect our patients daily. As such, we would like to clarify some of the issues raised in this article.
Since the Food and Drug Administration’s passage of the “Final Rule” ( 21CFR 50.24) in 1996, permitting an exception from informed consent in special emergency research circumstances, emergency medicine researchers have conducted research in critically important areas such as cardiac arrest and trauma. Simultaneously, our researchers have been proactive in developing efforts to safeguard patients and potential research subjects through intensive education and monitoring of this type of research and sharing of experiences among investigators engaged in this type of work. For example, SAEM spearheaded the Coalition of Acute Care and Resuscitation Researchers which helped to shape the FDA’s Final Rule and recently hosted a conference on the Ethical Conduct of Resuscitation research which included thought leaders, researchers, and ethicists all concerned about the adequacy of human subject protection in these circumstances.
Emergency treatment without consent is a longstanding concept that is very well accepted in our society. A patient injured in a car accident, unable to speak for him/herself would be cared for in an Emergency Department (“ER”), and would receive necessary life-saving treatment despite the inability to consent, based on the premise that a reasonable person would want this treatment. The United States legal system has upheld this standard of ”implied consent” based on the idea that physicians act in the best interest of a patient in a life-threatening situation and according to what a reasonable person would want.
The same principle can and must be extended to emergency research. It is not possible to get consent for emergency research that addresses critical emergencies – and it is this type of research that is absolutely critical to improving the emergency care given to patients in life-threatening situations! Without such research, we cannot make progress in the best way to perform cardiopulmonary resuscitation, the best way to revive someone in a coma from a medication overdose, or the best way to resuscitate a victim of a serious car crash.
As academic researchers whose intent it is to further the quality and number of proven emergency treatments available to patients with life-threatening illness and injury, we take offense to the statement made by George Annas, “This just seems like lazy investigators…” In fact, using the exception from informed consent regulations has nothing to do with laziness – but rather with the passion to do research to improve emergency care for our patients. Dr. Annas is overly simplistic and even callous when referring to the decision to treat a patient like flipping a coin. It is also erroneous for Dr. Annas to claim that providers already know which treatment is best and therefore consent is necessary. Investigating two treatments believed to be “equal” is absolutely necessary because in reality one treatment might really be better or even more harmful. The point is, no one knows at the outset – not the researchers or the providers – or the research would have no justification for being done in the first place. This is stipulated in the exception from informed consent regulations.
Emergency researchers who have applied the exception from informed consent regulations to their work can attest to the fact that they spend hundreds of additional hours and countless additional efforts to safeguard patients. They see this as necessary and it is done willingly in order to accomplish this important research and to advance the state of emergency care. Without these regulations, such research simply could not be done. Additionally, this research undergoes serious and lengthy scrutiny by Investigational Review Boards (IRBs) and community representatives before it begins. Patients are additionally protected by the critical review of many who are not part of the research team.
The American College of Emergency Physicians (ACEP) has summarized these issues in the Code of Ethics: “Emergency physicians shall communicate truthfully with patients and secure their informed consent for treatment, unless the urgency of the patient’s conditions demands an immediate response.” Because we often deliver an immediate response to save a life, we can and should deliver an immediate response to conduct life-saving emergency research, even if consent for that research is not feasible, based on the premise that reasonable persons would consent.
Sincerely,
Jill M. Baren, MD, MBE, FACEP, FAAP
Catherine A. Marco, MD, FACEP
Members of the Board of Directors, Society for Academic Emergency Medicine